Patient Safety Summit 2014
The War on C Diff Mark Mellow, MD
+ C Diff The Organism Gram + bacillus Anaerobic Spore forming Intestinal flora (up to 35% hospitalized patients, 3% of healthy adults) Leading cause of Antibiotic associated Diarrhea and colitis
+ Mode of Transmission Fecal-oral route Poor hand hygiene practices Poor infection control practices (use of contaminated equipment between patients) Spore dormancy
+ C Diff More Virulent New strain NAP1/027- makes 10-30 times more toxin
+ Key factors in contracting C Diff Antibiotic use, esp. Fluoroquinolones Proton Pump Inhibitors Renal failure HAND HYGIENE
+
C Diff recent IBMC Trends Cases LOS Deaths Routine d/c 9/1/06-8/31/07 206 16 27 (13%) 38% 9/1/07-4/30/08 270 18 45 (18%) 33% (annualized)
+ Demographics 7 DISCHARGE STATUS 45 61 ROUTINE DISCHARGE HOME UNDER CARE EXPIRED SNF / ICF / LTC OTHER 30 39 version 2 Perspective: Population with at least one positive test result.
+ War on C Diff Prevention Early Detection Better Treatment
+ C Diff prevention Isolation Gowns Gloves Handwashing-Chlorhexidine in all rooms BP cuffs, and stethoscopes in each room Room equipment sterilization Dr. recommendations: Trashcan near door, for gown, etc disposal Sink area uncluttered, large gloves. Nurse recommendations: Doctors need to follow precautions also!
+ Early recognition= Earlier isolation, earlier onset of treatment
+ Early Recognition Allow nurses to collect stool specimen for new onset diarrhea Stools are batched to lab in mid morning, so collect evening or early a.m. specimen Write Dr., phone order-doctor will sign in a.m.
+ War on C-Diff Results 04/08-3/09 C Diff 11.3 for 1000 admissions National Average 13 per 1000 04/09-03/10 C Diff 6.9 per 1000 admissions decrease 40%
+ Identify C Diff patients likely to have/develop severe diarrhea Age >65 Need for tube feeding last 30 days Chronically ill, debilatated WBC <500 Transplant patient Immunosuppressant use, including Prednisone 10mg/day Prior C Diff infection in last 12 months ICU patient Any patient who, as result of C Diff, has; WBC >15k, Cr 1.5x prior value; albumin <3
+ The Problem of Recurrent CDI 20-25% of patients experience recurrence if recurs, 40-50% have multiple recurrences Diarrhea, weight loss, debility, death Standard therapy is often ineffective- need innovative treatment
+ What is a Fecal Transplant? Obtaining fecal matter from a healthy person and placing it in the intestine of another person.
+ Are Humans really a Bacterial Species? We have 150 times as many bacterial cells as human cells.
+ The GI Tract has most of our bacteria- 10-100 Trillion 1,000,000,000,000
+ We know VERY LITTLE about our friendly bacteria We have always relied on culture techniques to identify bacteria Over 80% of non-pathogenic bacteria cannot be cultured New (high-tech) method DNA
+ Actions of Gut Microbes Pathogen resistance and clearance- bacteriocidins Immune modulation Nutrition and Metabolism Occupy Epithelial cell surfaces- block toxin attachment
+ Why would Fecal Transplant work? Antibiotics knock out many good bacteria that prevent C Diff proliferation Normal person s stool has these good bacteria
+ DECREASED MICROBIAL Diversity in RCDI Small Study Genomic analysis of types of bacteria in stool: Controls 1 st Attack of CDI Recurrent CDI Many fewer species in RCDI and in 1 PT with 1 st attackdeveloped recurrence 10 days later! Bacteria with colonizing resistance factors missing in RCDI
+ No butts about itfecal transplants work for some MSNBC
+ Don t poo-poo technique: Fecal transplant can cure superbug, doctors say CBC NEWS Nov.,2007
+ Fecal Transplant Process Donor identified- Significant other usually preferred Donor stool obtained-donor blood & stool tested~72hrs Patient tested (medicolegal) Discontinue CDI treatment 24-48hrs prior to transplant Donor takes a mild laxative night before transplant Donor stool obtained and liquefied with normal saline (non-bacteriostatic) 300-500cc s Liquid mixture instilled, on withdrawal, via colonoscopy PT given Imodium prior to leaving Endoscopy Unit
Long-term Follow-up of Colonoscopic Fecal Microbiota Transplant (FMT) for Recurrent C. difficile Infection (RCDI) Mellow M 1, Brandt L 2, Kelly C 3, Stollman N 4, Surawicz C 5, Aroniadis O 2, Kanatzar A 1, Park T 3, Rohlke F 4 1 INTEGRIS Digestive Health Center; OKC, OK 2 Montefiore Medical Center; Bronx, NY 3 Brown University; Providence, RI 4 Alpha Bates Summit Medical Center; Oakland, CA 5 Harborview Medical Center; Seattle, WA
+ FMT Survey 36 item questionnaire 94 eligible patients complete information on 77 (82%) 56 women, 21 men Age 65 (22-87) Post-FMT- 17 months (range:3-68)
+ FMT Questionnaire Pre-FMT Data Health Status Duration and Severity of C. difficile Previous Treatment Modalities Associated Risk Factors acid suppressants, renal disease Donor Characteristics relative, same household
Post-FMT Effect of FMT on symptoms & time to improvement Diarrhea Abdominal pain Weight loss Overall well-being Follow up stool testing for C. difficile toxin (if done) and results. If no improvement in diarrhea, were other treatments tried? List/effect.
Post-FMT Recurrence of diarrhea? How long after FMT? C. difficile-associated? Antibiotic-associated? How treated?
Post-FMT Other medical conditions present before FMT that resolved after FMT? New medical conditions that developed after FMT?
FMT: Patient Satisfaction Would patient undergo another FMT if they were to again develop C. difficile? After failing antibiotics once, twice, more Instead of antibiotics
+ FMT: Results on 77 patients 31 patients hospitalized, SNF, or homebound Duration of illness: 11 months 5 treatment courses Pulse-tapered Vanco: 25 patients Rifaximicin: 17patients Probiotics: 59 patients 6 Bowel movements a day: 52 patients Weight loss: 61 patients (mean 20 pounds) Severe fatigue: 41 patients
+ FMT: Donor Status Spouse or significant other: 46 patients 1 st degree relative:19 patients Other relative: 2 patients Friend: 9 patients Unknown to patient: 1 patient Resides in same household: 56 patients No correlation between donor status and outcome
+ FMT: Symptom Response Resolution of diarrhea Mean of 6 days 3 days in 57 patients Resolution of fatigue Mean of 4 weeks 1 week in 51 patients
+ FMT Primary cure Definition: resolution of diarrhea and no recurrence in 90 days Result: 70 of 77 (91%)
+ FMT Rx for Treatment Failures 2 weeks: Vanco:1 Vanco + Florastor: 1 Vanco + Alinia: 1 Vanco + Kefir: 1 2 week Vanco failure 2 nd FMT: 2 Not treated- hospice care/deceased: 1
FMT Outcome Secondary cure Definition: resolution of C. difficile after one further course of Vanco with or without repeated FMT Result: 76 of 77 patients (98%) 30 of 30 cured patients tested negative for C. difficile Asymptomatic patients were not routinely tested for cure
FMT Outcome: Subsequent Antibiotic Use 30 patients required antibiotics after FMT Range of 1-8 courses (mean-2) C. difficile recurred in 8 of 30 (27%) No C. difficile recurrence in any other patients
Effect on Other Conditions Improvement in pre-existing conditions Arthritis: 1 patient Allergic Rhinitis: 1 patient New medical conditions that developed Sjogren s: 1 patient ITP: 1 patient Rheumatoid Arthritis: 1 patient Non-diabetic Peripheral Neuropathy: 1 patient
+ No relationship between duration or severity of CDI symptoms and response to FMT
Patient Acceptance 53% preferred FMT as 1 st option if C. difficile were to recur
+ Conclusions-1 Primary cure in 91% Secondary cure in 98% mostly elderly, debilitated patients who previously failed multiple Rx courses including pulse/tapered Vanco, alternative antibiotics, and probiotics
+ Conclusions-2 Despite lengthy illness before FMT (11 months), response to FMT was rapid (mean 6 days) and sustained
+ Conclusions-3 No patient developed recurrent C. difficile in the absence of subsequent antibiotic use
+ Conclusions-4 Strong female predominance in recurrent C. difficile (73%)
+ Conclusions-5 Results were similar in all 5 centers
+ Conclusions-6 Colonoscopic FMT is a rational and safe treatment option for patients who have experienced 2 prior episodes of C. difficile
Patient Safety Summit 2014